1. Field of the Invention
The present invention relates to the field of the collection of amniotic fluid and placental aspirate. More particularly, the present invention relates to a system wherein amniotic fluid and placental aspirate can be collected at the cesarean section site, quickly processed, and reused as a medication for the patient. The present invention also relates to a kit for performing the system and method of the present invention.
2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 37 CFR 1.98
Caesarean section, or C-section, is the delivery of a baby through a cut in the mother's lower abdomen and the uterus. Today, it is one of the most frequently performed surgeries in the world, more commonly performed than gallbladder removal, hysterectomy, or tonsillectomy. A C-section may be lifesaving for the baby or the mother or both.
In a C-section, the first incision made is either a vertical incision in the middle of the abdomen, from below the navel down to the pubic bone, or a transverse or “bikini cut” incision, called an annesteil incision, from side to side just above the pubic hairline. The bikini cut incision is more common, because it heals better, has a shorter recovery time, and is more cosmetically acceptable. After going through the various layers of the abdominal wall and opening the bladder fold of peritoneum, the lower segment of the uterus is exposed. An incision is then made in the uterine wall. Usually, the incision is horizontal; this is preferred as it heals better and bleeds less. However, under some circumstances, it is necessary for the doctor to make a vertical incision in the uterus.
Recovery from a C-section generally takes longer than a vaginal delivery. During a C-section, the amniotic fluid and placenta are typically suctioned away or otherwise disposed of. This presents a missed opportunity, as amniotic fluid is known to have certain beneficial components, including growth factors. Placental aspirate also known to have beneficial components, including stem cells and platelets. The stem cells found in the placental aspirate could potentially be very useful, as the stem cells are less limited in their application than those of the most commonly available source of stem cells, bone marrow.
Typically, operating rooms are provided with a series of vacuum components, including a plurality of the vacuum suction lines whereby the liquid such as amniotic fluid can be removed from the surgical site and disposed of or used at a later time.
The separation of the components of liquid, most commonly blood, but is well-known. Numerous patents have issued in the past relating to separation of the components of blood, typically at utilizing centrifuges. U.S. Pat. No. 5,242,606 (the '606 patent) issued on Sep. 7, 1993 to Braynin et al. The '606 patent is an example of such a device for separating the plasma from whole blood. In the '606 patent, an analytical rotor is used having a sample application port in the upper surface thereof. Blood is introduced into the sample application port and metered into a metered chamber by capillary flow while the rotor remain stationary. Excess blood passes into an overflow chamber by capillary flow, either simultaneously with the metered flow or after opening of a vent in the overflow chamber. Subsequent rotation of the rotor causes metered blood in the metering chamber to flow into receiving chamber, typically a plasma separation chamber.
Cyclonic separation is also well known. For example, U.S. Patent Publication No. 2014/0047986, published on Feb. 20, 2014 to Robinson, describes systems and methods for salvaging red blood cells from patients during a surgical procedure. A system is described for cyclonically extracting blood from blood-soaked absorbent surgical materials such as surgical sponges, gauze, tape, and the like. The collected blood and fluids from these materials can be transferred to a cell salvage machine for harvesting viable red blood cells for autotransfusion.
Filtration of obstetrical fluids is also known, as well as filtration along a suction line. For example, refer to U.S. Pat. No. 4,957,629 (the '629 patent), issued on Sep. 18, 1992 Smith et al. The '629 patent describes a filter for obstetrical fluids and particulate matter having an enclosure containing a first chamber and a second chamber. The first chamber has a solid partition forming first and second cavities in the first chamber. The first cavity has an inlet and the second cavity has an outlet. The second chamber contains a filter and the edge of the partition is pressed against the surface of the filter.
The collection and reuse of amniotic fluid is also contemplated by others in the field. For example, refer to U.S. Patent Publication No. 2014/0336600 (the '600 publication), published on Nov. 13, 2014 to Harrell. The '600 publication describes a method for obtaining sterile amniotic fluid, as well as uses for such fluid. The '600 publication describes the use of a suction or a pump for collecting the amniotic fluid, as well as separation of cells such as growth factors and stem cells from the amniotic fluid. The '600 publication describes the separation of the growth factors and stem cells in a centrifuges remote from the collection site. The container utilizing in the '600 publication does not aid in the separation of the stem cells and growth factors. The process growth factors and stem cells collected using method of the '600 publication would not be suitable for or available for reuse as a medicine on the patient in which they were collected, as the separation of the cells occur to that location that time remote from the actual surgery. By the time the cells are separated and could possibly be reused, in all likelihood, the surgeon has since closed surgery site and moved on to the next procedure. Placental blood is also known to have stem cells and other beneficial components.
As such, there is a need for a system and method wherein stem cells and other beneficial cells from amniotic fluid and placental aspirate can be reused on the same patient so as to assist in the healing of the C-section wound.
It is an object of the present invention is to provide such a system and method to accomplish this goal.
It is another object of the present invention to provide a system for the collection of amniotic fluid which can be used with existing operating room equipment.
It is another object of the present invention to provide a system and method for the collection and processing of amniotic fluid and placental aspirate which allows for instant separation and reuse of the beneficial components of the amniotic fluid and placental aspirate.
It is another object of the present invention to provide a system for the collection and processing amniotic fluid and placental aspirate which is easy to use and does not require substantial amount of time in addition to the standard procedure.
It is another object of the present invention to provide a system and method for the collection and processing of amniotic fluid and placental aspirate which utilizes the amniotic fluid and placental aspirate speed healing and a cesarean section wound.
It is yet another object of the present invention to provide a system and method for the collection and processing of amniotic fluid and placental aspirate which utilizes an existing suction line to separate the beneficial components from the amniotic fluid and placental aspirate.
It is another object of the present invention to provide a kit having the components of the system described hereinabove.
These and other objects and advantages of the present invention will become apparent from a reading of the attached specification and appended claims.